This IV Psychedelic-Based Compound Completes Phase 2a Trial, Company Gets Extra IP Coverage

Short-acting psychedelics biotech company Small Pharma Inc. DMTTF announced that the last patient has completed its final visit in its Phase IIa clinical study of its proprietary intravenous (IV) DMT formulation SPL026 paired with supportive therapy for the treatment of Major Depressive Disorder (MDD.)

“This is the first completed placebo-controlled patient study to date exploring a short-acting psychedelic as a potential treatment for MDD, and we eagerly anticipate the results,” stated Small Pharma’s CMO and CSO Dr. Carol Routledge.

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The proof-of-concept Phase IIa trial included a blinded, randomized, placebo-controlled phase with a primary endpoint set at assessing the efficacy of a single dose of SPL026 versus placebo. Additionally, all participants were rolled into an open-label phase where they received an active dose of SPL026 plus follow-up for 12 weeks. 

This trial design, therefore, enabled the analysis of secondary endpoints including efficacy (through MADRS score), safety, and tolerability of one vs. two doses of SPL026.

Dr. Routledge explained that the next steps are data analysis and topline results reports expected shortly thereafter, most likely by 2023’s first quarter. 

Advancing IP Protection: New European Patent 

Small Pharma was granted a novel patent by the European Patent Office covering a manufacturing process for the preparation of synthetic DMT, DMT-related compounds and deuterated DMT analogs, effectively protecting the company’s pipeline candidates, SPL026 and SPL028.

The patented process is a Good Manufacturing Practice (GMP) compatible formula, reportedly inexpensive and therefore commercially scalable while the European patent is the first grant within Small Pharma’s synthetic route patent family. Additionally, the company holds patent applications pending in several jurisdictions including the U.S. and Canada.

“Innovation is a key pillar of our Company strategy, and we have made great strides this year in protecting the intellectual property portfolio surrounding our innovation,” said Small Pharma’s CEO George Tziras. 

The CEO explained that this European grant raises the company’s patents to 14, “including key grants within each of our core areas of patent protection,” and that Small Pharma closes the year with “great momentum” and looks forward to continuing that same path in 2023. 

Photo by Kelly Sikkema on Unsplash